510(k) K140558
K140558 is an FDA 510(k) premarket notification submitted by Access Pharmaceuticals, Inc. for the device "PROCTIGARD". The FDA issued a decision of Substantially Equivalent on July 16, 2014. The device falls under product code PHN (Protective Coating, Mucoadhesive Application, For The Rectal Mucosa), a Class U device. Access Pharmaceuticals, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 16, 2014
- Date Received
- March 5, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Protective Coating, Mucoadhesive Application, For The Rectal Mucosa
- Device Class
- Class U
- Regulation Number
- Review Panel
- GU
- Submission Type
Mucoadhesive application for the protective coating of the rectal mucosa.